Balloon tamponade

ABSTRACT

An implantable device for controlling hemorrhage in a body cavity comprising an expandable balloon and a conduit for supplying a physiologically compatible fluid to inflate the balloon is described. The balloon tamponade device is inserted into the body cavity and is inflated with a physiologically suitable fluid so that the balloon generally conforms to the body cavity and exerts compressive force against the walls, tissues or structures of the body cavity to control hemorrhage. The balloon may have a deforming means to limit expansion of the balloon in a direction to facilitate expansion of the balloon in another direction. The device may have additional tubes within the conduit, or a plurality of separate lumens within the conduit or tubes to allow drainage and irrigation to the body cavity. A method of controlling hemorrhage in a body cavity by using the implantable device is also contemplated.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.12/069,314 filed Feb. 8, 2008, now U.S. Pat. No. 9,055,949, issued Jun.16, 2015, which claims the benefit of U.S. Provisional PatentApplication Ser. No. 60/900,714, filed Feb. 9, 2007. The disclosure ofeach of which is expressly incorporated herein in its entirety by thisreference.

BACKGROUND OF THE INVENTION 1. Field of the Invention

The present invention relates generally to the field of medicine and,more particularly, to a balloon tamponade device and methods forcontrolling hemorrhage in a body cavity.

2. Related Art

The pelvis is the bony structure located at the base of the spine. Eachhipbone (os coxae) consists of three bones: the ilium, ischium, and thepubis. The two hipbones are joined anteriorly at the symphysis pubis andposteriorly to the sacrum. The pelvis incorporates the socket portion ofthe hip joint for each leg and forms the lower limb girdle of theskeleton. The pelvic cavity is a body cavity that is bounded by thebones of the pelvis and that primarily contains the reproductive organs,the urinary bladder, the appendix, part of the large intestine and therectum. The abdominal cavity contains the stomach, spleen, liver, gallbladder, pancreas, small intestine and part of the large intestine. Theabdominal cavity is not physically separated from the pelvic cavity, andfrequently the cavities are referred to collectively as theabdominopelvic cavity.

Loss of blood internally into the abdominopelvic cavity occursfrequently with blunt trauma, blast injuries, pelvic fractures andabdominal or pelvic surgeries (e.g., hysterectomy), that cause injury tothe network of blood vessels lying on the inner wall of the abdominalcavity and/or pelvic cavity. Up to 52% of patients with pelvic fractureswill develop hemorrhagic shock in the emergency department. Themanagement of abdominal and pelvic hemorrhage has been limited to morerigorous interventions, including pharmaceutical (e.g., recombinantFactor Vila), surgical (e.g., vascular ligation, such as hypogastricartery ligation) and radiological (e.g., selective arterialembolization). Packing of the pelvic cavity (e.g., Logothetopulos,mushroom or umbrella pack) has been used to control pelvic hemorrhage,but there is no commercially available product. Pelvic packing isperformed by the physician in situ using a sterile bag (e.g., a trashbag, X-ray cassette drape, etc.) that is packed with gauze or otherpacking material that may later be removed from the bag. See, Dildly etal., “An Effective Pressure Pack for Severe Pelvic Hemorrhage,” Obstet.& Gynecol. 108(5):1222-1226 (2006). However, pelvic packing is difficultto insert, may not provide pressure where most needed (at the specificsite of bleed or near involved vasculature), and may mask continuedbleeding, making it difficult to determine whether hemorrhage has beeneffectively managed by the pelvic pack.

Significant blood loss may also occur in gynecologic and obstetricpatients, for example, due to trauma, abortion procedures, vaginal orcesarean delivery (e.g., lacerations to uterus, vagina or broad ligamentor retained placental tissue), or due to a variety of other causes,including, placental abruption, placenta previa, placenta accreta orplacenta percreta or placenta increta, uterine atony, uterine inversion,coagulation disorders, chronic endometritis and placental polyps.Treatments to manage gynecologic/obstetric hemorrhage include: bloodproduct (e.g., blood or platelet transfusion) and/or pharmaceuticalintervention (e.g., Factor Vila or other clotting mediators, anduterotonics, such as oxytocin, prostaglandins, misoprostol,methylergonovine, carboprost tromethamine, dinoprostone), uterinemassage and compression sutures, surgical procedures (e.g., vascularligation of the iliac, hypogastric, uterine and/or ovarian arteries),and interventional radiology procedures (e.g., selective arterialembolization). Hysterectomy is the measure of last recourse,particularly if the patient is of low parity.

Uterine and vaginal packing, similar to pelvic packing, have been usedto treat uterine and vaginal hemorrhage, but packing forgynecologic/obstetric hemorrhage has largely been replaced by use ofballoon catheters that were originally developed for other purposes,such as Foley catheters, Rusch catheters and Sengstaken-Blakemore tubes.See, L. W. Bowen and J. H. Beeson, “Use of a Large Foley CatheterBalloon to Control Postpartum Hemorrhage Resulting from a Low PlacentalImplantation,” J. Reprod. Med. 30:623-628 (1985); G. S. Condous, et al.,“The Tamponade Test in the Management of Massive Postpartum Hemorrhage,Obstet. and Gynecol. 1201 (4):767-772 (2003). The SOS Bakri TamponadeBalloon Catheter (manufactured by Cook Medical Inc., Bloomington, Ind.)is the only commercially available balloon catheter specificallydeveloped for management of postpartum hemorrhage from an intact uterus.Y. N. Bakri, “Uterine tamponade-drain for hemorrhage secondary toplacenta previa-accreta,” Int. J. Gynecol. Obstet. 27:302-303 (1992); Y.N. Bakri, “Balloon device for control of obstetrical bleeding,” Euro. J.Obstet. Gynecol. Reprod. Biol. 86:S84 (1999); and Y. N. Bakri, et al.,“Tamponade-balloon for obstetrical bleeding,” Int. J. Gynecol. Obstet.74:139-142 (2001). Balloon tamponade devices to manage vaginal anduterine hemorrhage are disclosed in U.S. Pat. Nos. 4,552,557; 5,062,425;5,571,153; 5,674,239; 6,024,753; 6,520,977; 6,676,680; 7,220,252; andU.S. Patent Application Publication Nos. 2006/0173486, 2005/0049627, and2004/0030352.

However, there are disadvantages in existing balloon catheters used foruterine or vaginal hemorrhage. Existing balloon catheters are of a smallvolume (maximum full of 500 milliliters or less), and cannot be rapidlyfilled (inflated with a fluid) because the elasticity of the ballooncreates a counter-inflation pressure that must first be overcome. Forexample, it takes significant applied pressure to inflate a Bakridevice, delaying full inflation time (the inflation necessary to exertcompression) for three-minutes or more. Also, when these ballooncatheter devices are used to control uterine hemorrhage, externaltraction is applied to the lower portion of the balloon device so thatit properly sits at the base of the lower uterine segment. Traction tothe balloon tamponade requires a means to prevent the balloon catheterfrom being pulled downward into the vagina. Typically, the vagina isseparately packed (even if not bleeding) to prevent the uterine balloontamponade from being pulled by traction into the vagina, resulting inyet additional delay and preventing rapid control of uterine hemorrhage.Furthermore, it is frequently desirable to simultaneously controlhemorrhage in the uterus and vagina, but there is no unitary device toprovide a tamponade to both such body cavities.

Due to the substantially larger volume of the abdominopelvic cavity,none of these existing vaginal or uterine balloon catheter devices issuitable for controlling hemorrhage in the pelvic or abdominal cavity.Thus, there is a need for an effective means to control hemorrhage froman abdominal or pelvic cavity. There is also a need to controlhemorrhage from an abdominal or pelvic cavity that does not mask acontinuing bleed. Further, there is a need for a device to controlhemorrhage that provides separate lumens for administering fluids to thebody cavity and for draining body fluids and debris from the bodycavity. Further, there is a need for an apparatus having the ability tosimultaneously control hemorrhage from a uterus and a vaginal bodycavity. There is also a need for an effective means to rapidly controlhemorrhage in a body cavity.

The present invention is directed to overcoming one or more of theproblems set forth above. The invention described herein is not limitedin any manner by the descriptions or definitions, or the diagnostic orclinical indications or uses described herein.

BRIEF SUMMARY

The present invention relates to an apparatus (sometimes referred toherein as a “balloon tamponade”) to control hemorrhage in a body cavityand, unless otherwise provided herein, “body cavity” shall mean a pelviccavity, abdominal cavity, a uterus or a vagina. After the apparatus isimplanted or inserted into a pelvic cavity or abdominal cavity, theballoon is inflated to expand the balloon to a shape within the bodycavity. Expansion of the balloon so that it generally conforms asclosely as possible to the shape of the body cavity, causes acompressive force or pressure against a wall, tissue, structure or asite that is bleeding and thereby controls hemorrhage from the bodycavity. The apparatus of the present invention may also be used as aprophylactic device in patients who may be expected to experienceinternal hemorrhage in a body cavity (e.g., due to trauma or surgery orother medical condition), such that the device is implanted beforehemorrhage begins and may prevent hemorrhage or limit the severity ofhemorrhage that does occur.

Specifically, in one aspect of the invention, there is provided anexpansible, deformable material (referred to herein as a “balloon”) anda conduit, the balloon sealaby surrounding at least a portion of theconduit. The conduit has a first lumen (a first inflation lumen) influid communication with the interior of the balloon to provide achannel to inflate the balloon when it is implanted in a body cavity.The conduit is further comprised of a second lumen and a deforming meansto deform the shape of the balloon so that a balloon dimension ischanged in an axis or a direction. Deformation of the balloon changesthe dimension of the balloon in a first direction or axis, causingexpansion and compressive forces to be directed in a preferred seconddirection or axis. For example, deforming the balloon at the domechanges the shape from an ellipse in the longitudinal axis to an ellipsein the lateral axis, thereby directing expansion more laterally in theposterior/anterior axis, against the sides of the body cavity.

In yet other preferred embodiments, the conduit of the pelvic balloontamponade extends the length of the balloon and is sealably surroundedby the balloon at the distal and proximal ends of the balloon. Theconduit comprises an inflation lumen and a second irrigation/drainagelumen. The irrigation/drainage lumen has a distal end and a proximal endand lumen openings at or near the opposing distal and proximal ends ofthe conduit, in communication with the pelvic or abdominal cavity andthe exterior of the subject's body, to deliver fluids to (irrigate)and/or receive fluids and debris from (drain) the pelvic or abdominalcavity. In yet another aspect, the tube may have separate irrigation anddrainage lumens to minimize contamination of the body cavity that mayoccur when irrigation and drainage is accomplished through the samelumen. In still other embodiments, separate inflation lumens anddeflation lumens may be provided, each lumen being in communication withthe balloon interior, to permit circulation or replacement of theinflation media while maintaining substantially continuous pressurewithin the balloon interior, which is preferred when warming or coolingof the body cavity is desired.

In yet another embodiment, the balloon apparatus provides a means tocontrol hemorrhage from separated areas within the body cavity or from abody cavity and a natural or created lumen or orifice in the body (e.g.,a pelvic cavity and a vagina, or a pelvic cavity and an orifice createdin a perineum). In a preferred embodiment, the balloon apparatuscomprises at least two balloons axially spaced along the inflation tube,each balloon capable of being inflated to control hemorrhage from theseparate areas. In other preferred embodiments, separate inflationlumens are provided so that the balloons may be separately anddifferentially inflated, or such that only one of such balloons may beinflated.

In other embodiments, the balloon apparatus may further comprise anintroducer or guide to assist insertion and placement of the balloonapparatus when inserted through a lumen or channel in a subject (e.g.,insertion through the vagina of a female subject who has had ahysterectomy or insertion through an opening created in the perineum ofa male subject). In yet other embodiments, a rigid or semi-rigid collarlocated at the base of the balloon is provided to secure a tractionmeans to the apparatus, thereby preventing displacement of the balloonapparatus or upward movement of the balloon apparatus further into thebody cavity. In still other embodiments, the balloon apparatus mayfurther comprise one or more connecting means (such as fittings,luers/leurs, adapters, etc.) to connect a lumen of a tube or conduit ofthe balloon apparatus to tubing and/or to an inflation media source thatis external to the body. In still other embodiments, the balloonapparatus may further comprise a control means to retain the inflationmedium within the balloon. Control means (e.g., valves, stop-cocks,clamps) may also be provided to seal and unseal a lumen of a tube or tocontrol influx or efflux through the lumen of tubing, tubes or conduitsof various embodiments of the invention. In still other embodiments, theballoon apparatus may further comprise a pressure detection means, suchas a pressure gauge, to detect the internal pressure of the media withinthe balloon.

In yet another aspect of the invention, there is provided a method ofcontrolling hemorrhage from a pelvic or abdominal cavity by inserting orimplanting an expansible balloon into a pelvic or abdominal cavity of asubject that is experiencing (or may be expected to experience)hemorrhage. Once implanted, the balloon is inflated with a biologicallyand physiologically compatible fluid, and is retained in its inflatedstate within the body cavity at a pressure and for a period of time, asmay be determined by clinical judgment to be sufficient to controlhemorrhage. Preferably, the inflation pressure (internal pressure) ofthe balloon would be maintained at or just above the blood pressure ofthe subject. The inflated balloon apparatus may be retained in thesubject for any suitable period of time, in most instances, fromapproximately 20 minutes to 72 hours, and preferably only as long as isnecessary to determine that hemorrhage has been effectively controlled(evidence of clotting, no further bleeding from the body cavity, orother sign of hemostasis), or that damage is so severe that the balloonapparatus cannot adequately manage hemorrhage such that more significantintervention is required (e.g., surgical or radiological intervention).Medical personnel may assess whether hemorrhage has been controlled orstaunched by release of the inflation medium from the balloon (bysuction or release or opening of a control means).

In still another aspect, the invention provides a balloon tamponade kit,comprising a balloon apparatus, one or more inflation supply tubes,drainage effluent tubes, a fluid collection means and instructions foruse and implantation of the device.

Further aspects, features, embodiments and advantages of the inventionwill be apparent from the following disclosure, the claims and thedrawings.

BRIEF DESCRIPTION OF THE DRAWINGS

The invention will be better understood and further features, detailsand advantages of the invention will appear more clearly with referenceto the diagrammatic drawings, illustrating specific embodiments of theinvention by way of non-limiting example only:

FIG. 1 illustrates a cross-sectional view of a non-inflated embodimentof a balloon tamponade of the invention.

FIG. 2 illustrates an isometric elevation of a non-inflated, folded orpleated balloon of the invention.

FIG. 3 illustrates a front elevation of a non-inflated, folded orpleated balloon of the invention.

FIG. 4 illustrates a cross-sectional view of an inflated dual balloontamponade of the invention.

FIG. 5 illustrates an elevation of an inflated dual balloon tamponade ofthe invention.

FIGS. 6A-6G illustrate cross-sectional views of conduits havingconfigurations of lumens suitable for various embodiments of theinvention.

DETAILED DESCRIPTION

The following description includes a description of the best mode ormodes of the invention as presently known. The descriptions are notintended to in any way limit the invention and are examples given onlyfor illustration, so that by reference to the accompanying drawings, oneskilled in the art may appreciate the features, aspects, and advantagesof the invention.

The present invention for controlling hemorrhage in a pelvic orabdominal cavity of a subject comprises an expansible material (e.g., aballoon) that is implanted in the body cavity and, when inflated by afluid medium, generally conforms to the shape of the body cavity,exerting a compressive force against at least one wall, surface,structure or site (e.g., a bone, a blood vessel, an organ or a tissue)to control hemorrhage from the body cavity. The various embodiments ofthe apparatus disclosed herein are sometimes referred to herein as a“balloon tamponade” and/or “balloon apparatus.” When used herein inreference to a balloon of the present invention, the following termsshall have the following meaning: “deflated” shall mean a condition ofthe balloon immediately prior to and after insertion, followed by“fill,” which indicates that the balloon has been inflated, thenfollowed by “drain” in which the inflating fluid is released so that theballoon returns to the deflated state (e.g., the condition of theballoon prior to removal under intended use conditions); “deform” shallmean a feature or attribute of a balloon that allows the shape of theballoon to be changed when desired; “conform” shall mean a condition ofa balloon wherein the balloon has changed shape to substantially mirrorthat of the implantation site; “compliance” shall mean a feature orattribute of a balloon that allows the balloon to change shape tosubstantially mirror that of the implantation site in response to aresistance force within the body cavity (e.g., due to encountering awall, structure or tissue or organ) or in response to a traction orother force applied to the balloon.

Referring now to the drawings, wherein like numerals designate like andcorresponding parts throughout the several views, in FIG. 1 is shown aballoon tamponade apparatus 200 for controlling hemorrhage in a pelvicor abdominal body cavity, comprising an expansible material (balloon)100 having a distal end 190 (in reference to placement in the subject, acephalic end) and a proximal end 180 (in reference to placement in thesubject, a caudal end), and a conduit 30 having an inflation lumen 32 incommunication with the interior 50 of the balloon through one or aplurality of openings 34. The inflation lumen 32 provides a means toinflate or fill the balloon interior 50 with a fluid medium (e.g., gasor liquid), thereby expanding the balloon to a shape within the bodycavity. The inflation lumen also provides a means to deflate theballoon, by efflux or withdrawal of the inflation medium from theballoon, so that the apparatus may be removed from a body cavity of thesubject. Preferably, at least a portion of the tube is sealablysurrounded by the balloon, the seal providing a means to retain theinflation medium within the balloon interior and to secure the tube tothe balloon.

The balloon is made of an expandable material, such as natural rubber,synthetic rubber, silicone, latex, urethane (polyurethane),polyvinylchloride, polyethylene, nylon or any other expansibleelastomer, polymer or other material. Preferably, the balloon is formedof biocompatible, sterilizable material that is ultrasonic/radio opaqueand may be treated with antimicrobial agents. Most preferably, theballoon will have sufficient compliance to generally conform to theshape, contours, walls and structures of a pelvic or abdominal cavity.However, it should be recognized by one in the art that, in certaincircumstances, it may be preferable to have a balloon that isnon-resilient and/or non-conforming and that will generally retain itsoriginal shape after inflation. In a preferred embodiment shown in FIG.5, a vaginal balloon 150, having a cylindrical or oval shape, will benon-conforming such that it retains the cylindrical or ovoid shape wheninflated within a vagina.

The balloons of various embodiments of the invention may be of anyshape, contour, size and volume. Preferably, the shape, contour, sizeand volume are such that, when inflated, the balloon will generallyconform to the body cavity where hemorrhage is to be controlled (i.e.,the interior wall or surface or structure of the pelvis or abdominalcavity). Most preferably, the balloon will substantially conform to thebody cavity. Conformance of the exterior shape of balloon with theinterior wall, surface or structure of the body cavity enables theballoon to fit against a wall, surface, or structure, thereby exerting acompressive force or pressure to control hemorrhage. The balloon mayhave folds, ribs, channels, undulations and/or other formations orcontours to increase the expandable surface area of the balloon, or tofacilitate expansion to a desired shape, or to facilitate conformance ofthe balloon with an interior surface, or to enhance balloon complianceto accommodate specific features, structures, tissues or organs of thebody cavity. As shown in FIGS. 2 and 3, the balloon may comprise aplurality of folds or pleats to facilitate rapid fill or inflation to“fill volume” of the balloon, by overcoming the elasticity of theexpansible material. Shapes particularly suited to the pelvic andabdominal cavities include spherical, mushroom, teardrop, heart orwinged, ovoid, oblong and cylindrical. Balloons of the invention may bemade by any conventional method known in the art, such as by extrusionor dip molding.

The balloon is constructed to be inflated by and hold a biologically andphysiologically compatible medium, preferably a fluid and mostpreferably a liquid such as water or saline, or any other liquid usedfor intravenous infusion, such as Ringer's, lactated Ringer's, sterilewater for injection, or sterile normal saline. The size and volume ofthe balloon will be determined by the body cavity or select area of abody cavity where hemorrhage control is desired. Balloons may be of anysize or volume. Preferably, balloon tamponades suitable for pelvic andabdominal cavities may be inflated or filled with fluid volumes betweenapproximately 500 milliliters and approximately 5 liters, while balloontamponades suitable for a uterine or vaginal cavity may be fromapproximately 200 milliliters to approximately 1 liter. If bleeding isknown to originate from a particular area of a body cavity, a smallersize and volume balloon appropriate for the select area may be used tolocalize pressure to the select area of the body cavity. Also, male andfemale anatomy and subject size (e.g., adult vs. child) may dictate theshapes, contours, size and volume of the balloon that is suitable forcontrol of hemorrhage from a body cavity of such a subject. For example,a balloon tamponade for a child may require a balloon volume capacity ofapproximately 500 milliliters to approximately 1 liter, while a balloontamponade for a large adult male may require a balloon of approximately3.5 liters to approximately 5 liters.

In certain preferred embodiments, a balloon suitable for a pelvic orabdominal or uterine cavity may be of a size having 400 milliliters atneutral inflation (un-inflated), and 1 liter upon full fill volume wheninflated. Most preferably, a balloon suitable for a pelvic or abdominalor uterine cavity may be of a size having 800 milliliters neutralinflation and 1.5 liters full fill volume when inflated. The deformationforce (application of internal balloon traction means) should have nomore than 10 N when inflated to full fill volume pressure, mostpreferably no more than 3 N when inflated to full fill volume pressure.Preferably, the diameter of the balloon before insertion (in theun-inflated state) will be no more than 3 centimeters, most preferablyno more than 1 centimeter. The diameter of the balloon at deflation(removal diameter) is preferably no more than 4 centimeters, and mostpreferably no more than 2 centimeters. In certain preferred embodiments,a balloon suitable for a vaginal cavity may be of a size having adiameter of 10 centimeters and a length of twenty centimeters when fullyinflated, preferably a diameter of 12 centimeters, and a length of 25centimeters when fully inflated.

The tubes, tubing or conduits of the balloon tamponade apparatus andvarious aspects, features and embodiments of the invention, may be madeof any biocompatible material, such as natural rubber, synthetic rubber,silicone, latex, urethane (polyurethane), polyvinylchloride,polyethylene (e.g., low density polyethylene), nylon, polycarbonate orany other biocompatible, flexible elastomer, polymer or other materialsuitable for tubes, conduits, tubing and catheters. However, it shouldbe recognized by one in the art that in certain circumstances, it may bepreferable to have a conduit (or part of a conduit) that is lessflexible or inflexible, rigid or semi-rigid (non-resilient and/ornon-conforming), such as a portion of a conduit contained within avaginal balloon. Preferably, the tube, conduit or tubing is formed ofsterilizable material that is ultrasonic/radio opaque and may be treatedwith antimicrobial agents. Most preferably, the tube, conduit or tubingis made of polyethylene, silicone or nylon. As used herein, the conduitmay comprise a single tube having a single lumen, multiple tubes eachhaving one or more lumens, a tube within a tube and each tubing havingone or more lumens, or an extruded conduit having a plurality of lumenswithin the extruded conduit, in each instance, having lumen diameters,lumen lengths and openings as suited to the particular purpose of thelumen. The “working length” of a lumen (i.e., the length needed toaccomplish its function) may be changed by plugging or skiving theindividual lumen to achieve desirable length to achieve or perform aparticular function. For example, drainage and irrigation lumens willextend beyond the distal and proximal ends of the balloon, so that eachsuch lumen may be in communication with a body cavity at or near thedistal end of a balloon, and at the proximal end, be in communicationwith the exterior of the subject's body. An inflation lumen may notextend the length of the balloon at the distal end, but may extendbeyond the proximal end and have an opening in communication with theexterior of the subject's body for connection to a source of inflationmedia.

As more fully described below, the tube or conduit or tubing of variousembodiments of the invention may comprise one or a plurality of lumens,the lumens having one or a plurality of openings for fluid communicationwith a balloon interior or a lumen or a separate tube or conduit or abody cavity. As shown in FIGS. 6A-6G, lumens may be provided in anyarrangement suitable for a particular embodiment of the inventiondescribed herein. FIGS. 6A and 6B illustrate a single tube having twolumens; FIGS. 6C and 6D illustrate a single tube having three lumens;FIGS. 6E and 6F illustrate a single tube having four lumens. The tubesand conduits of the balloon tamponade and, in particular, those tubesand conduits that are physically contained within or surrounded by theballoon, are preferably sufficiently inflexible or rigid or inelastic tomaintain their inner diameter when the balloon is inflated (e.g., madefrom a more rigid/inelastic material than the balloon or have a thickercross-section than the wall of the balloon). The inflation lumen shouldbe of a diameter sufficiently large to allow rapid inflation or fillingof the balloon. Preferably, the inflation lumen will be of a diameter toallow inflation or filling of the balloon in approximately three minutesor less, and most preferably in one minute or less. An inflation supplymeans may be provided to inflate the balloon, such as a large syringe, apump (e.g., an infusion pump), a filled IV fluid source (e.g., a bag orbottle) or other receptacle for holding a fluid, preferably a sterilesealed container readily available to medical personnel to contain orsupply a physiological fluid.

As show in FIG. 4, in another aspect, the invention provides a deformingmeans for deforming the shape of the balloon or limiting expansion ofthe balloon in a first direction, so that when the balloon is inflated,more force is exerted in a second direction against a wall or surface orstructure (e.g., a bone, a blood vessel, an organ or a tissue) withinthe body cavity to control hemorrhage. The deforming means may be anysuitable means to limit expansion of an expansible material or to exerta deforming, resistive or opposing force to expansion of a wall of theballoon during inflation of the balloon or to change the dimension of aballoon or change the shape of a balloon. For example, in a preferredembodiment, as shown in FIG. 4, traction means 115 (e.g., a wire, cable,filament, or other tensile attachment) is attached by a tractionconnecting means 110 (e.g., a loop, an adhesive, a fitting, etc.) to awall at the distal end 190 of the balloon and extends the length of theballoon to a traction application means 120, such as a tab, a grip, aring, a ratchet, a clamp, a friction wheel, a bead or step catch, orother latching or locking means or other means to apply a traction forceto the traction means. Placing a traction force (e.g., pullingdownwardly) on the traction application means 120 during inflation (orafter inflation) will deform the expansible shape of the balloon, limitupward expansion of the balloon, and cause the balloon to expand morelaterally, thereby selectively causing pressure laterally and downwardlyalong the sides and base of the body cavity. Alternatively, a tractionwire, cable, filament or other tensile or tensioning means may beattached (fixedly or releasably) to a portion of the conduit 30 or to aninternal cuff 130 surrounding the conduit at or near the proximal(caudal) end of the balloon, which provides a traction force duringinflation to deform the shape of the balloon or limit upward expansionof the dome (distal/cephalic end) of the balloon. Alternatively, thedeforming means may be an area or wall of expansible material havingless expansibility or elasticity than another area or wall of theballoon, thereby deforming the balloon shape or limiting the expansionof the balloon in that area. For example, the deforming means may be acap or disk within a wall of the balloon, or a collar (rigid orsemi-rigid) disposed over a wall or area of the balloon. In yet anotherembodiment, the deforming means may be a second balloon that, wheninflated or filled, provides a resistive force against expansion of thefirst balloon.

In yet another embodiment, the traction means may be the cuff of theballoon disposed (rolled) inside the balloon during assembly toeffectively position the cuff approximately medial to a portion of theconduit surrounded by the balloon interior, wherein the conduit providedthereby becomes a traction means. When tension is applied to theconduit, the proximal end of the balloon “roll ups” over the cuff,deforming the balloon's shape to more elliptical in the lateral orhorizontal axis than in the longitudinal axis, and forcing the proximalend of the balloon to conform to the surrounding anatomy of the bodycavity.

In yet another embodiment, a balloon may be formed of an expansiblematerial that increases in thickness in an area of the wall of theballoon, thereby limiting the expansibility of the balloon at thethicker wall, deforming the shape of the balloon and causing expansionof the balloon to be directed in areas where the balloon wall is oflesser thickness or greater expansibility. Most preferably, thethickened area is at the distal or cephalic end of the balloon so thatexpansion is limited at the cephalic end or in the cephalic-caudal axis,thereby facilitating expansion of the balloon laterally (dorsal axis)and in the anterior (front) and posterior (back) axis.

As shown in FIGS. 5 and 6B, in yet another embodiment of the invention,the balloon tamponade apparatus comprises an expansible balloon and aconduit, a conduit 30 comprising an inflation lumen 32 in communicationwith the interior of the balloon, and a drainage/irrigation lumen 70that extends beyond the distal (cephalic) end of the balloon and havinga distal opening 72 in communication with a pelvic or abdominal cavityand a proximal opening 78 in communication with the exterior of thesubject's body. Preferably, the distal and proximal openings are locatedat or near opposing ends of the drainage/irrigation lumen. Thedrainage/irrigation lumen provides a means to drain the body cavity(e.g., of blood, debris, and irrigation fluids) and to irrigate the bodycavity with cleansing and hydrating fluids (e.g., water or saline) andtherapeutic agents (e.g., pharmaceuticals) or diagnostic instruments. Inan alternative embodiment as shown in FIGS. 6C-6G, the balloon tamponadeapparatus provides separate irrigation 72 and drainage 74 lumens tominimize contamination of the body cavity (e.g., due to return of debristo the body cavity during supply of irrigation fluid). Preferably, theproximal end of the conduit comprising the drainage/irrigation lumen(whether a single lumen or separate lumens) extends outside the body tofacilitate irrigation and collection of drainage materials. Preferably,the drainage lumen has a diameter sufficient to permit removal (byflushing or suction) of debris (pieces of tissue, cells, blood clots)that may enter the drainage tube, and to prevent such debris fromblocking drainage of fluids through the drainage lumen.

In a preferred embodiment, as shown in FIG. 5, the balloon tamponadecomprises a conduit assembly having a distal end and a proximal end, afirst balloon 100 and a second balloon 150 co-axially spaced along theconduit, wherein the conduit assembly is sealably surrounded by each ofthe first balloon and the second balloon and comprises a first inflationlumen (40 as shown in FIG. 6G), in communication with the interior ofthe first balloon interior and a second inflation lumen (42 as shown inFIG. 6G) in communication with the interior of the second balloon. Thefirst balloon has at least a fold or pleat to facilitate rapid fill andinflation and is axially spaced along the conduit adjacent to the distalend of the conduit. The second balloon is of a cylindrical shape and isnon-conforming to substantially retain the cylindrical shape uponinflation. In the conduit assembly, the second conduit is slidablydisposed over the first conduit and the conduit assembly comprises thelumen configuration shown in FIG. 6G. The second conduit has a jointdisposed between the first and second balloons, wherein the joint iscomprised of a joint fitting 152 to allow the second balloon to bedisjoined from the first balloon at the joint. The joint fitting 152 maybe a friction bit, a snap fitting, a threaded fitting, a taper-fit, acollar, a bayonet fitting, or a quick-release fitting.

In still other embodiments, the balloon apparatus may further compriseone or more connecting means to connect a lumen of conduit to a lumen ofa tube or to a medium source (e.g., irrigation fluid or inflationmedia), or to a drainage receptacle, or to a control means or pressuredetection means (as described below) that is located external to thebody. Any conventional connecting means may be employed, such asluers/leurs, lugs, locks, lock nuts, rings, fittings, Y connectors,adapters, connecting means described in U.S. Pat. No. 6,520,977 (whichis incorporated herein), and any other means suitable for connectingtubes, conduits, tubing, or control means. Connecting means for use inmedical applications are commercially available and well known in theart. Preferably, where an IV bag is the inflation supply source, theconnecting means for connecting an inflation lumen to inflation supplysource is a bag spike to puncture an IV bag to facilitate rapid fill ofthe balloon.

In yet other embodiments, a control means is provided to seal or unseal,or retain or release, or regulate flow of fluids through, the lumens ofthe tubes, conduits and tubing of the invention. The control means maybe any means suitable for sealing and unsealing, or regulating flowthrough a lumen, or to control influx or efflux through the lumen or toretain or release a fluid within a lumen. Control means may includevolume flow regulators, valves (e.g., ball valves or needle valves),stop-cocks, clasps, clamps (e.g., pinch, spike, slide and rollerclamps), clips, caps, plugs, stoppers and any other means suitable forsealing or unsealing a tube or conduit or tubing. Such control means foruse in medical applications are commercially available and well known inthe art. Preferably, control means for irrigation tubes or lumens have ameans to provide flow in one direction (e.g., one-way valves) to preventreverse flow. Control means for the deflation lumen or drainage lumenpreferably comprise a one-way stopcock.

In yet other embodiments, the balloon tamponade may further comprise ameans to detect the level of pressure within the balloon interior, suchas a simple pressure gauge. The pressure detection means may beconnected by connecting means to the inflation lumen. During inflationof the balloon, the pressure gauge needle will pulse in concert with thesubject's heartbeat. When the balloon is inflated with sufficientpressure (i.e., at or just above the blood pressure of the subject), thepressure gauge needle will cease pulsing.

In yet other embodiments as shown in FIG. 5, the balloon tamponadeapparatus may further comprise an external traction connecting means 175for attachment of an external traction source 300 to apply externaltraction to the balloon tamponade apparatus after inflation has beencompleted. External traction source 300 may be any means to apply atraction force in the caudal direction, such as by manually pulling,attaching a weight or a filled IV bag/bottle or by taping a tractionline to a subject's leg. External traction to the balloon tamponadeprovides yet another means to apply compressive force in the caudaldirection toward the base of the body cavity. The external tractionsource 300 is attached to external traction connecting means 175(fixedly or releasably) by an attachment means 185, such as a wire,filament or string. Preferably, the external traction connecting means175 comprises a semi-rigid cuff or rigid cuff having a fastening meansfor fastening an external traction attachment means to the cuff. Thecuff may be sealably or removably attached to a conduit of the balloontamponade, preferably at or adjacent to the proximal end of the conduit.

In certain embodiments of the balloon tamponade, the apparatus mayfurther comprise an introducer assembly for aiding insertion of theballoon tamponade apparatus into a pelvic or abdominal cavity from anopening in the body (for example, in a hysterectomy patient through thevagina, or in a male patient through an incision in the perineum). Theintroducer assembly is generally used to prevent the balloon tamponadedevice from flexing excessively during insertion. The introducerassembly comprises a wire attached to a gripping means at a proximalend. The wire is threaded from the proximal end to the distal end of alumen of the conduit and extends substantially the length of theballoon. Preferably, the introducer wire is threaded through a lumenthat is not in communication with a body cavity (e.g., not threadedthrough an irrigation lumen or drainage lumen). Preferably, the wire ofthe introducer assembly extends to within one or two centimeters fromthe distal end of the lumen. Generally, the introducer assembly isremoved from the lumen of the balloon tamponade after balloon tamponadeinsertion and placement in the body cavity has been accomplished. Thewire may comprise a trocar, guide, stem, stylet or other semi-rigid orrigid means to aid insertion of a tubular medical device (e.g., acatheter) into a subject. The traction wire described above may alsofunction as an introducer in certain embodiments of the invention. In analternate embodiment, the introducer may be surrounded by a drain tubeor an irrigation tube. The insertion means may be hollow or solid andmay be made of any suitable material that will not damage the balloon orthe body cavity, or the organs or tissues of the subject, such asnatural or synthetic rubber, latex, semi-rigid polymers (e.g.,polyethylene or polyvinyl chloride or polycarbonate), or of metal.

In other embodiments, an external surface of the balloon may be coated(e.g., by layer, film, spray, gel or powder), impregnated, infused,permeated or otherwise comprise a hemostatic material or apharmaceutical composition in order that the hemostatic material orcomposition may come into general contact with a wall, tissue, orstructure within a body cavity. Any pharmaceutical may be used, andhemostatic agents such as oxidized cellulose, hemotene, thrombin, FactorVII, and other blood-clotting factors are particularly suitable for usein connection with the balloon tamponade.

In a preferred embodiment shown in FIG. 5, the balloon tamponadeapparatus comprises a first balloon having a distal end and proximalend, sealably surrounding a portion of a first conduit having a firstlumen and in communication with the interior of the first balloon. Atthe proximal end of the balloon, the balloon meets an external portionof the first tube at an internal cuff 130. The first conduit 250 extendsto the exterior of the body and is connected to a control means formaintaining the balloon in an inflated state and for controllablyreleasing fluid from (deflating) the balloon when pressure to the bodycavity is to be reduced or when the device is to be removed from thebody cavity.

In a preferred embodiment, there is provided a balloon tamponade forcontrolling hemorrhage in a body cavity of a subject, comprising anexpansible balloon comprising a plurality of folds or pleats, and havinga distal end and a proximal end. The device further comprises a conduitsealably surrounded by the balloon, having a distal end and a proximalend and having an inflation lumen, a guide lumen, an irrigation lumenand a drainage lumen. A traction means (preferably a wire or cable)extends the length of the guide lumen. A traction connecting means,preferably a cuff, is disposed along the conduit at or near the proximalend of the conduit. The inflation lumen is in communication with theinterior of the balloon and the guide lumen is in communication with aninterior surface at the distal end of the balloon. The irrigation lumenand drainage lumen are each in communication with a body cavity throughopenings at or near the distal end of the conduit and are each incommunication with the exterior of the subject's body through an openingat or near the proximal end of the conduit. The traction means isattached to an interior surface of the balloon at the distal end of theballoon and is attached to a traction connecting means (e.g., cuff) atthe proximal end of the conduit.

In yet another embodiment, a dual balloon tamponade for controllinghemorrhage in a body cavity comprises a first balloon and a secondballoon, each having a distal end and a proximal end. The first ballooncomprises a plurality of folds or pleats. A first conduit, having adistal end and a proximal end, comprises a first inflation lumen incommunication with the interior of the first balloon, and is sealablysurrounded by the first balloon. A second conduit has a distal andproximal end and comprises a second inflation lumen in communicationwith the interior of the second balloon. The second conduit is sealablysurrounded by the second balloon and the second conduit is slidablyarranged over the first conduit. A first semi-rigid cuff disposedbetween the first and second balloons, surrounds either the proximal endof the first conduit or the distal end of the second conduit. In otherembodiments, the first conduit further comprises an irrigation lumen anda drainage lumen, each of the irrigation lumen and drainage lumen havingan opening in communication with a body cavity and an opening incommunication with the exterior of the subject's body, to providechannels for irrigation of and drainage from the body cavity. Fittingmeans may be provided for releasably fitting the second conduit to thefirst conduit. Such fitting means may include a friction bit, a snapfitting, a threaded fitting, a taper-fit, a collar, a bayonet fitting,or a quick-release fitting.

FIG. 6A illustrates yet another embodiment, in which the inflation lumenmay comprise a bifurcated lumen 32 a and 32 b, and each one of suchbifurcated lumens may be attached to a control means, thereby allowingsimultaneous infusion/inflation to and drainage of a physiologicalmedium from the balloon interior, or allowing the physiological mediumwithin the balloon to be exchanged as needed (e.g., allow for fluidreplacement) without altering the pressure within the balloon. Thebifurcation of the inflation lumen also permits substantially continuouscirculation of a physiological medium into and out of the balloon, suchas when heating or cooling of the body cavity is desired. In a preferredembodiment, an additional tube provides an inflow and outflow means fora physiological medium capable of being heated or cooled, thus providinga means to heat or cool the physiological medium within the ballooninterior where the tube may constitute one or more lumens in an open orclosed-loop configuration, with or without exchange external to thetube. Specifically, a loop may be created of a tube such that thediameter is compatible with existing peristaltic or infusion or otherpumps and heat or cooling sources, so that the fluid within theballoon(s) may be circulated in a closed loop by the pump through a heator cooling source in order to increase or decrease body cavitytemperature.

In yet another aspect, the invention provides a rapid-fill balloon forcontrolling hemorrhage in a body cavity, comprising an expansibleballoon having a plurality of folds or pleats. The balloon has a fluidfill volume (volume upon full inflation) of between 300 and 1000milliliters, and is capable of being inflated to fill volume in lessthan three minutes without requiring application of pressure to overcomethe elasticity of the balloon.

In yet another aspect of the invention, there is provided a kit forcontrolling hemorrhage in a pelvic or abdominal cavity, comprising anembodiment of the expansible balloon tamponade apparatus describedherein, and instructions for use of such material, and packaging forcontaining the balloon tamponade apparatus and instructions. In another,preferred embodiment, the balloon tamponade kit further comprises adrainage receptacle and a connecting means to releasably connect thedrainage lumen to the drainage receptacle to collect fluid and debristhat is discharged from the drainage lumen. In still other embodiments,the kit may further comprise inflation supply tubing and/or irrigationsupply tubing and/or drainage efflux tubing, or any combination thereof,together with connecting means suitable for connecting such inflationsupply, irrigation supply or drainage efflux tubing to the balloontamponade apparatus. In certain preferred embodiments, the kit mayfurther comprise a pharmaceutical agent, such as a hemostatic agent thatmay be applied to the surface of the balloon before implantation. Thekit may further comprise digital or electronic information andinstructions on use, insertion and implantation of the balloon tamponadedevices, such as a video cassette, compact disk (CD), digital video disk(DVD), flash or zip or thumb drive, or any other means to electronicallystore information that may be accessible by a computer.

Another aspect of the invention provides a method to control hemorrhagein a body cavity, by providing a balloon tamponade in an unfilled(non-inflated) state, implanting or inserting the balloon tamponade intoa body cavity (with or without the assistance of an introducer), fillingthe balloon with a biologically and physiologically compatible fluidthrough the inflation lumen of the tube (preferably a warmed or cooledsterile fluid) supplied from an external inflation media supply source,such as a filled IV bag or a syringe filled with the inflation medium.The physiologic medium is supplied at a pressure and volume sufficientto inflate the balloon (or the particular balloon of a dual balloontamponade, as applicable). During the infusion of the physiologicmedium, the balloon distends and its effect on bleeding is observed byefflux from a drain tube. Preferably, the effluent is collected formeasurement and evaluation. The preferred inflation pressure of theballoon is the lowest pressure that controls bleeding from theparticular body cavity in which it is placed and, most preferably, thepressure that staunches bleeding from the body cavity of the subject.

When the desired volume or pressure is reached in the balloon interior,a control means may be manipulated to cease further infusion of theinflation medium and/or to retain the inflation medium in the ballooninterior and the inflation lumen. The external source of the medium isdisconnected, and a drainage bag or other drainage collection receptaclemay be releasably attached by connecting means to the drainage lumen (orto a drainage efflux tubing connected to the drainage tube through aconnecting means) to capture drainage fluid. Optimum pressure isdetected, for example, when there is no further fluid drainage from thedrain tube or when blood clots are observed in the drain tube,indicating that normal coagulation has been restored in the subject.After an appropriate length of time, balloon pressure may be lowered(fluid gradually drained or released from the balloon through theinflation or deflation lumen, as applicable) and observations made todetermine whether or not bleeding has been controlled (i.e., whetherbleeding is observed in the drain tube). If bleeding is observed uponrelease of balloon pressure, then the balloon may be re-inflated to anappropriate pressure to control hemorrhage.

These and other aspects, features and advantages of the presentinvention are apparent from the detailed description when taken inconjunction with the drawings. In addition to the objects, features andadvantages in the embodiments and examples described above, otherobjects, features and advantages of the present invention will beapparent to those skilled in the art. The disclosed aspects are merelyillustrative of the innumerable aspects associated with the presentinvention and should not be deemed as limiting in any manner. Althoughmethods and materials similar or equivalent to those described hereinmay be used in the practice of the present invention, suitable methodsand materials are described above. The materials, methods and examplesare illustrative only and not intended to be limiting in any manner.While preferred examples and steps of the present invention have beenillustrated and described, this has been by way of illustration and theinvention should not be limited except as required by the scope of theappended claims and their equivalents.

What is claimed is:
 1. A dual balloon tamponade for controllinggynecologic and obstetric hemorrhage in a body cavity of a subjectcomprising: a first expansible balloon having a distal end and aproximal end; a second expansible balloon having a distal end and aproximal end, the second expansible balloon co-axially spaced from thefirst expansible balloon; a first conduit having a distal end and aproximal end, the first conduit being sealably surrounded by the firstexpansible balloon and having a first inflation lumen in communicationwith an interior of the first expansible balloon; a second conduithaving a distal end and a proximal end, comprising a second inflationlumen in communication with an interior of the second expansible balloonand being sealably surrounded by the second expansible balloon, thesecond conduit being slidably disposed over the first conduit; and ajoint fitting to allow the second expansible balloon to be selectivelyslidably disjoined from the first expansible balloon along the firstconduit, and further wherein the joint fitting comprises a friction bit,a snap fitting, a threaded fitting, a taper-fit, a collar, a bayonetfitting, or a quick-release fitting.
 2. The dual balloon tamponade ofclaim 1, wherein the first expansible balloon is axially spaced from thesecond expansible balloon along the first conduit adjacent the distalend of the first conduit.
 3. The dual balloon tamponade of claim 1,further comprising a deforming means configured to deform the shape ofat least one of the first expansible balloon and the second expansibleballoon by limiting expansion in a first direction such that when the atleast one of the first expansible balloon and the second expansibleballoon is inflated, increased force is exerted in a second directiondifferent from the first direction.
 4. The dual balloon tamponade ofclaim 1, wherein the second expansible balloon includes a shape having amaximum length between approximately 20 centimeters and approximately 25centimeters upon inflation.
 5. The dual balloon tamponade of claim 1,further comprising a deformation force of no more than approximately 10N when inflated to full fill volume.
 6. The dual balloon tamponade ofclaim 1, further comprising a deformation force of no more thanapproximately 3 N when inflated to full fill volume.
 7. The dual balloontamponade of claim 1, wherein each of the first expansible balloon andthe second expansible balloon can be filled with fluid volumes betweenapproximately 200 milliliters and approximately 1,000 milliliters. 8.The dual balloon tamponade of claim 1, further comprising at least oneof an irrigation conduit and a drainage conduit extending from alocation proximal of the second expansible balloon to a locationproximate the distal end of the first expansible balloon.
 9. The dualballoon tamponade of claim 8, further comprising both an irrigationconduit and a drainage conduit.
 10. The dual balloon tamponade of claim1, further comprising a traction application structure located betweenthe proximal end of the second expansible balloon and the proximal endsof the first and second conduits.
 11. A kit comprising: a. the dualballoon tamponade of claim 1; b. a drainage collection receptacle forcollecting fluid discharged from a body cavity; and c. a set ofinstructions for use and implantation of the dual balloon tamponade. 12.The kit of claim 11, wherein the instructions comprise digitalinstructions.
 13. The kit of claim 11, further comprising a syringe.